FDA-Device2014-12-17Class II
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Pfm Medical Inc
Hazard
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Sold states
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Affected count
1470 units
Manufactured in
1815 Aston Ave Ste 106, N/A, Carlsbad, CA, United States
Products
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0562-2015Don't want to check this manually?
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